FOSTER CITY, Calif October 18, 2021
Gilead Sciences, Inc. (Nasdaq: GILD) announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy.
The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children.
While effective available treatment options for pregnant women living with HIV lower the likelihood of perinatal HIV The approval of Biktarvy for children weighing at least 14 kg is based on data from Cohort 3 of a Phase 2/3 open-label, single-arm study (NCT02881320), which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1. Cohort 3 enrolled 22 participants weighing ≥14 to <25 kg who continued on treatment for 48 weeks and could then continue to receive study drug through an extension phase. After switching to Biktarvy, 91% (20/22) of participants remained virologically suppressed at Week 24, and the mean change in CD4 % from baseline was 0.2%. HIV-1 RNA was not collected at Week 24 for two participants because of COVID-19 pandemic-related study disruption. In pediatric studies, no new adverse reactions or laboratory abnormalities were identified compared to those observed in adults.
Biktarvy is a complete HIV-1 treatment that combines 3 powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete single-tablet regimen and should not be taken with other HIV-1 medicines.
Biktarvy does not cure HIV or AIDS.